This role requires 4-days onsite in our Cambridge, MA office.
Fully remote is not eligible.
Job Description
The Senior Clinical Study Lead (CSL) operates with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
The Senior CSL is accountable for the study timelines, ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
Responsibilities
* Leads cross-functional study team responsible for clinical study delivery and serves as primary point of contact for leadership and oversight.
* Provides operational input into protocol development.
* Oversees and provides input to development of study specific documentation.
* Ensures compliance with clinical trial registry requirements.
* Identifies outsourcing needs of the study and leads engagement, contracting and management of required vendors.
* Monitors progress for site activation and monitoring visits.
* Develops and oversees implementation of patient recruitment and retention strategies.
* Ensures accurate budget management and scope changes.
* Escalates issues related to study conduct, quality, timelines or budget.
* Oversees data quality, including regular review of data metrics and listings.
Requirements
* Exceptional interpersonal & leadership skills.
* Applies advanced expertise and implements operational strategic direction for respective clinical studies.
* Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
* Strong budget management experience.
* An awareness of relevant industry trends.
* Ability to build, lead, and develop productive study teams and collaborations.
What We Offer
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to protected characteristics.